Biomedical Engineering Reference
In-Depth Information
100 CHAPTER 5. FUTUREDIRECTIONS
ination or reduction of the immune reaction is currently sought through the removal of the
α
-galactosyl carbohydrate structure and through decellularization of xenogeneic implants.
The FDA regulates food, drug, and medical device safety through several Centers and Offices.
As compliance requirements differ with each Center, it is important for a tissue engineering
company to consider which pathway to market a product might take.
Most orthopaedic implants have been classified as devices. Pathways to market for devices
include filing for the 510(k), PMA, PDP, or HDE applications. While several cell and biologic
products are available for cartilage resurfacing in Europe, few have been approved in the US.
